ISO 13485 implementation & optimization
FDA 21 CFR Part 820 & MDSAP alignment
QMS documentation, process mapping & audit readiness
Integration with regulatory submission requirements
DHF creation, remediation & gap closure
FDA 21 CFR 820.30 & ISO 13485 design controls
Traceability, V&V mapping & change control documentation
Audit-ready DHF for global submissions
Device classification & regulatory strategy
Technical documentation & clinical evaluation
Notified Body coordination & conformity assessment
Post-market surveillance & vigilance support
UK regulatory pathway & classification strategy
Technical file preparation & UK compliance alignment
UK responsible person support
Market access & post-market obligations
Regulatory strategy & pathway assessment
FDA 510(k) submission & predicate identification
QMS alignment with FDA requirements
FDA communication & post-clearance support
Device classification & regulatory planning
Medical Device Marketing Authorization (MDMA) support
Technical documentation & SFDA submission
Post-approval compliance & lifecycle management
Medical device classification (Class A–D)
CDSCO registration, import & manufacturing licenses
NSWS / MD Online portal submissions
Query handling & post-approval compliance
Regulatory assessment for veterinary devices
India & global registration strategy
Technical documentation & compliance alignment
Market access support for animal health products
BIS applicability & product scope assessment
Documentation preparation & testing coordination
Factory inspection & certification support
Compliance maintenance & renewals
Regulatory risk assessment for investments & M&A
Approval status, compliance & documentation review
Market-wise risk classification (critical / major / minor)
Pre-close & post-close regulatory action planning
Regulatory pathway assessment (drug-led vs device-led)
Design & development documentation
Risk management, clinical & performance evidence
Global submission support for combination products